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510(k) K101835

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 by Porex Surgical, Inc. — Product Code HBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2010
Date Received
July 1, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
Submission Type

Other clearances by Porex Surgical, Inc.

  • K102184 — MEDPOR CONTAIN CAN IMPLANT (January 7, 2011)
  • K091807 — MEDPOR FIXATION SYSTEM (June 28, 2010)
  • K091120 — MEDPOR CONTAIN IMPLANT (March 19, 2010)
  • K083621 — MEDPOR CUSTOMIZED SURGICAL IMPLANT (February 3, 2009)
  • K071335 — MEDPOR ATTRACTOR IMPLANT (August 8, 2007)
  • K052297 — POREX ELECTROSURGERY NEEDLE (March 28, 2006)
  • K040851 — MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM (July 16, 2004)
  • K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (June 30, 2004)
  • K021357 — MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT (August 5, 2002)
  • K012350 — MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL (March 14, 2002)

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